02 — Capability · BC-1140
Manufacturing Quality & Compliance
Make sure what the plant ships matches what was specified and what the regulator was told, by controlling the process, inspecting at the right points, containing nonconformance and proving all of it on request.
- Plant Quality
- Quality Control
- Manufacturing Compliance
- Production Quality Assurance
In scope
- Incoming, in-process and final inspection and test
- Statistical process control and the response to out-of-control conditions
- Nonconformance, containment, disposition and corrective action in the plant
- Calibration, batch records and the audit and certification evidence a plant must keep
Out of scope
- The enterprise quality management system, policy and product-level quality planning (see BC-550)
- Design verification and validation of the product itself (see BC-530)
- Supplier quality development and supplier audits (see BC-640)
Realized by · 0
- No product in the catalog yet.
Used in · 1
- Plan-to-Produce · 05 Control Quality via BC-1140.10
Build it · 0
- Nothing in the library points here yet.
Decomposes into · 5
- BC-1140.10Inspection & TestCheck materials, work in process and finished product against their specifications at the planned points, with results recorded so that every accepted unit has evidence behind it.
- BC-1140.20Process ControlKeep critical process parameters inside their limits and detect drift before it produces defects, so quality is built in at the operation rather than sorted out at the end.
- BC-1140.30Nonconformance & Corrective ActionContain suspect product the moment it is found, decide what happens to it and remove the cause, with the whole chain recorded from first alert to verified closure.
- BC-1140.40Calibration & Measurement EquipmentKeep every gauge, instrument and test fixture that makes a quality decision calibrated, traceable and within tolerance, with a record that stands up to an auditor.
- BC-1140.50Quality Records & Audit ReadinessMaintain batch records, certificates and the plant's quality system evidence so that an internal, customer or regulatory audit is a review of what exists rather than a scramble to create it.